Chromatography Data Systems Services

Bob McDowall has used chromatography data systems in various types over his whole career (disc integrators to client server data systems). As editor of the Questions of Quality column in LC-GC magazine, he has written a five part series on the acquisition, validation and retirement of chromatography data systems. These articles are available for down load below:

Cut the existing list of articles on the web site to her here

QualifyPLUS® CDS Validation Package

McDowall Consulting offers clients the QualifyPLUS® generic chromatography data systems validation package; a package of documentation that is customised for the CDS package and an individual laboratory’s ways of working. See the attached file for a fuller description of the documentation package and approaches to customise it. File for download

This is a proven and scalable approach to the validation of chromatography data systems:

Scaleable Approach

The documentation has been used to validate most of the major chromatography data systems; it is scalable as it has been used on installations with as few as 8 users and as high as 350 users.

Proven Approach

The completed CDS validation packages have been discussed and reviewed by regulatory agencies including the FDA and no observations raised. Moreover, the packages have been reviewed favourably by internal compliance groups of the organisations that have used the package.

Cost Effective Approach

Ideally, this package should be used at the start of the CDS project to obtain the maximum benefit and learn from the principles taught. The package can be used to reduce the time to validate a CDS system. For example, the validation of a CDS in a major multinational pharmaceutical company was estimated to take 10 months, however using the QualifyPLUS® approach the first phase rollout was achieved in 3 months.

Case Studies

Published case studies using the QualifyPLUS® generic CDS validation package are:

• Millennium 2020 client-server system at Astra Hassle in Gothenburg, Sweden was retrospectively validated using the QualifyPLUS® CDS validation version 2 material. The work was published in LC-GC Europe in February 1999 with Bengt Wikenstedt, Per Johansson and Bob McDowall as co-authors, this is available as a down load link to file.
• Papers describing the prospective validation of the Analyst Version 1 LC-MS-MS software used in a GLP bioanalytical environment and the migration of data from the Macintosh platform into Analyst are in preparation and will be published in 2001. This validation used QualifyPLUS® CDS validation package version 3.

Current on-going work on the validation of chromatography data systems using version 4 of the package includes the following projects:

• Millennium 32 version 3.20: a client with 350 registered users on a single server.
• TurboChrom version 6.1.2. This is an upgrade from TurboChrom professional; prior to implementing the system, the current process has been mapped and bottlenecks identified. The aim is to redesign the process to be electronic records and electronic signatures compliant and to improve turnaround time for the client. Costs for the upgrade and validation should be recovered within 12 months with improved processes and electronic ways of working.
• Retrospective validation of Atlas 98 with technology transfer to the client’s staff to undertake the prospective validation of Atlas 2000.
• Validation of ChemStation version 8 and ChemStore for 21 CFR 11 compliance.

Course on Validation of CDS

We off prospective clients a one day training course on the validation of CDS, ideally this should be held at the start of a CDS project but can also be held at the start of the performance qualification phase of the work if required. Like all our course, customisation is offered to allow clients to obtain the fullest value from their investment in training.

Should have a file of this around the site